Kornimate/medical-research-clean huggingface dataset:
no need to ventilate: a trial of non-invasive inhaled nitric oxide in persistent pulmonary hypertension of the newborn

Conditions: Pulmonary Hypertension

Summary: the primary objective of the trial is to determine the feasibility and clinical safety and efficacy of non-invasive inhaled nitric oxide in infants with pphn without significant pulmonary +-parenchymal disease who would normally receive inhaled nitric oxide only after placement of a tracheal tube and the institution of mechanical ventilation.

blending low doses of no gas with oxygen in the inspiratory limb of mechanical ventilators is an effective method for reducing pulmonary vascular resistance and decreasing extrapulmonary right-to-left shunting at the ductus arteriosus and foramen ovale in many patients with pphn. however, in some patients with pphn, sustained elevations of pvr may occur in the absence of or despite improvement in the parenchymal lung disease such that mechanical ventilation is not needed for maintaining adequate gas exchange. ppn in the absence of pulmonary parenchymal disease or despite improvement in the parenchymal lung disease occurs in a significant subset of newborn infants with hypoxemic respiratory failure. inhaled no can be effectively delivered by non-invasive techniques to newborn infants with pphn, potentially reducing the duration of mechanical ventilation, while safely treating the elevation in pulmonary artery pressure and right-to-left. a dose of 10-20 ppm measured within the delivery device is sufficient to maintain nasopharyngeal concentrations within a range of 1-10 ppm. my co-authors and i have also reported a series of eleven infants with pulmonary hypertension treated with low dose ino delivered via nasal cannula after extubation at the 14th annual cnmc symposium on ecmo \& advanced therapies for respiratory failure, keystone, co, 1998.

Eligibility criteria:
inclusion criteria: * newborn infants \>/= 34 weeks with clinical or echocardiographic evidence of pphn with a pao2 \< 100 of fio2 0.8 who are not mechanically ventilated exclusion criteria: * infants with significant lung disease * inability to sustain spontaneous respirations * lethal congenital anomalies * severe birth asphyxia

Keywords: persistent pulmonary hypertension non-invasive inhaled nitric oxide ino
impact of insecticide resistance on vector control

Conditions: Malaria, Falciparum

Summary: the purpose of the study is to determine whether long lasting insecticidal nets and indoor residual insecticide spraying, alone or in combination, are effective for controlling insecticide resistant anopheles mosquitoes for malaria prevention.

the study will assess the impact that insecticide resistance has on the effectiveness of malaria vector control tools llin and irs. this is done by a cluster randomised trials of universal coverage llins versus universal coverage llins in combination with irs, with levels of baseline insecticide resistance in the main vector balanced between the two study arms. in each cluster resistance to the insecticide used on llins is monitored, and malaria incidence is estimated from cluster specific cohorts of children followed up over the duration of the study. resistance impact will be assessed from the ratio of incidence rates in clusters with high compared to those with low resistance and from a continuous measure of resistance expressed as percentage loss of mosquito mortality when exposed to insecticide in standardised who tests. resistance mechanisms will be studied in subsets of study clusters.

Eligibility criteria:
inclusion criteria: * children older than 6 months and younger than 10 years in approximately 100 randomly selected households in all 140 study clusters selected in the four study areas exclusion criteria: * children living in households within 1 km from the edge of a neighbouring cluster (the buffer zone)

Keywords: mosquito control insecticide resistance
wound infiltration with local anesthetic agent for laparoscopic appendectomy in adult

Conditions: Appendicitis Acute

Summary: acute appendicitis is one of the most common acute abdomens that need surgical intervention. laparoscopic surgery much decreases postoperative pain of wound, however, pain remains an important determinant of recovery after surgery. intraoperative local anesthetic agent infiltrated locally into surgical wound to relieve postoperative pain is a feasible and safe method suggested in some literature. however, there is no routine use of this method in clinical practice because its benefit is still unknown. besides, very few evidence could be found in literature review. to date, there is still no double blinded, prospective, randomized control trial addressing in evaluation of its interest. in this study, the investigators aim at investigating the benefit of wound infiltration with local anesthetic agent (bupivacaine) for laparoscopic appendectomy in adult. the study design is a double blind, prospective, randomized control trial with a 1:1 allocation ratio. fifty adult patients with appendicitis will be included. the control group undergo laparoscopic appendectomy without wound infiltration with local anesthetic agent, the intervention group undergo laparoscopic appendectomy with wound infiltration with local anesthetic agent intraoperatively. the clinical characteristics, outcomes, and patient's satisfaction will be recorded and analyzed. the investigators hope this study can provide a high level evidence in pain management of patient undergo laparoscopic surgery.


Eligibility criteria:
including criteria: 1. clinical diagnosis of appendicitis and undergo laparoscopic appendectomy 2. age more than 20 years 3. well comprehensive in speaking chinese exclusion criteria: 1. age no more than 20 years 2. pregnancy 3. can not cooperate with evaluation 4. convert to open surgical method, resect more organs than appendix 5. using patient control analgesia 6. allergy to local anesthetic agent

Keywords: adult appendectomy appendicitis local anesthesia pain
treatment of depersonalization disorder with transcranial magnetic stimulation (tms)

Conditions: Depersonalization Disorder

Summary: the purpose of this study is to evaluate the clinical efficacy of transcranial magnetic stimulation in the treatment of depersonalization disorder (dpd).

this study is a research trial of an outpatient, non-medication, non-invasive investigational treatment called transcranial magnetic stimulation (tms). tms applies a magnetic field to the brain for a brief period of time. tms is a procedure that involves 30 minute-long daily sessions every weekday for a series of weeks. the investigators are testing whether tms can treat depersonalization disorder (dpd). this is an open-label study. all patients will receive active treatment. dpd symptoms will be monitored through weekly self-report questionnaires as well clinical ratings with a doctor.

Eligibility criteria:
inclusion criteria: * male or female outpatients, 18 to 70 years of age. * primary diagnosis of depersonalization disorder. * duration of the index episode of at least a year. * patients currently on dpd medication must be at the same stable dose(s) at least 2 months and be to continue at the same dose(s) through the duration of the study. * capable and willing to provide informed consent exclusion criteria: * individuals with a neurological disorder including, but not limited to: brain lesion; history of seizures; history of cerebrovascular accident; history of stroke; cerebral aneurysm, dementia; parkinson's disease; huntington's chorea; multiple sclerosis. * increased risk of seizure for any reason, including prior head trauma with loss of consciousness for 5 minutes or more. * cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease. * intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed. * if participating in psychotherapy, must have been in stable treatment for at least three months prior to entry into the study, with no anticipation of change in frequency of therapeutic sessions, or the therapeutic focus over the duration of the rtms trial. * known or suspected pregnancy. * women who are breast-feeding

Keywords: dissociative dissociation depersonalization depersonalization disorder transcranial magnetic stimulation tms depersonalization disorder (dpd) rtms
the validity of maximal diaphragm thickening fraction to measure diaphragm function in mechanically ventilated patients

Conditions: Diaphragm Injury; Weaning Failure; Mechanical Ventilation Complication

Summary: this study is designed to determine whether maximal diaphragm thickening fraction measured by ultrasound during volitional maximal inspiratory efforts is a valid measure of diaphragm function in mechanically ventilated patients.

classically, assessing diaphragm function requires direct measurements of transdaphragmatic pressure generation. a critical requirement for valid measurements is a maximal volitional patient effort. an alternative is to standardize the stimulus to the diaphragm using magnetic twitch stimulation fo the phrenic nerve. this is the gold standard technique for diaphragm function measurement in the respiratory physiology laboratory. twitch measurements require technical expertise and expensive equipment; this technique is therefore basically limited to the laboratory. bedside ultrasonography has been proposed as a method for measuring diaphragm function by assessing the thickening of the muscle during a maximal inspiratory effort. in order to achieve a maximal volitional effort in mechanically ventilated patients, several methods may be employed: coached maximal efforts, coached sniffing, and transient airway occlusion to stimulate respiratory drive (marini maneuver). the investigators are evaluating the validity of diaphragm functional assessment using bedside ultrasound in combination with coached efforts/sniffing/marini maneuver against the gold standard technique: twitch transdiaphragmatic pressure.

Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old) with acute respiratory failure receiving invasive mechanical ventilation via endotracheal tube or tracheostomy * patients who meet readiness-to-wean criteria (triggering the ventilator; fio2 ≤ 50%; peep ≤ 8 cm h20; hemodynamic stability) exclusion criteria: * contraindication to phrenic nerve stimulation (chest tube; cardiac pacemaker or implanted defibrillator; cervical implants; use of neuromuscular blocking agents within the 24 hours preceding the first diaphragm assessment (with the exception of succinylcholine used during rapid-sequence induction of anaesthesia for intubation); cervical spine injury; known pregnancy) * patients experiencing an acute exacerbation of an obstructive lung disease (chronic obstructive pulmonary disease (copd), asthma, bronchiectasis)

Keywords: diaphragm function acute respiratory failure weaning
efficacy of the mydcombi on pupillary dilation in pediatric and adult patients

Conditions: Dilation; Pupil Reaction Absent

Summary: to raise the standard of care, improve the overall patient experience and streamline practice flow, eyenovia has developed an innovative mydriatic to be delivered as a microdose by a specialized dispenser. while still achieving effective pupil dilation, mydcombi has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery. the proposed study hopes to demonstrate the non-inferiority of using mydcombi to achieve pupillary dilation in patients compared to standard of care eye drops.

the proposed study strives to demonstrate the non-inferiority of using mydcombi to achieve pupillary dilation in patients compared to standard-of-care (soc) eye drops in a randomized trial. primary aim: demonstrate non-inferiority of using mydcombi to achieve pupillary dilation compared to standard-of-care eye drops in patients. participants 2 years or older undergoing standard pupillary dilation will be randomized to use mydcombi in one eye and standard of care pupillary dilation in another eye.

Eligibility criteria:
inclusion criteria: * receiving pupillary dilation in both eyes as part of the participant's standard of care. exclusion criteria: * pupillary or anterior segment abnormality * participants with pre-existing health conditions that would prevent pupillary dilation.
evaluation of caries prevention based on genetic etiology and risk.

Conditions: Caries,Dental

Summary: dental caries affects billions of people worldwide and involves saliva immunodeficiency, commensal pathogen and exposure (lifestyle) causal subtypes of the disease. up to 85% of adolescents in swedish and other low prevalence populations are caries-free while the remaining 15% show high, recurrent caries activity. accordingly, there is a lack of cost-effective risk assessment and prevention tools for personalized oral care. this randomized adaptive clinical trial (rct) evaluates both caries prevention based on genetic etiology and risk, as a consequence of saliva immunodeficiency genes specifying individuals as susceptible or resistant to caries, and the effect of intensified versus selfcare traditional prevention on the two groups.

this is a protocol for a multicenter risk assessment and intervention study (precaries) with an adaptive component. the study design comprises a prescreen of 2000 adolescents of which 520 will be included in the rct study part with adolescents undergoing ordinary orthodontic treatment with multibrackets at the public dental service. the orthodontic treatment allows for rapid caries development and improved discrimination between susceptible versus resistant individuals. the children are genotyped into two risk groups; genetic susceptible and non-susceptible children that are assigned to intensive or traditional standard prevention. the clinical outcomes will adaptively be measured at different time points (0, 6, 12 and months) as caries lesions at different teeth and surfaces using tactile, visual and x-ray bitewing, clinical photos and quantitative laser fluorescence (qlf). secondary outcomes will be inflammation at the gingival margins and pocket depth at debonding of the orthodontic appliances. questionaires are collected as well as biological samples; swab-dna, whole and parotid saliva and microbiota. human and microbiota geno-and protein typing involves in and ex house platforms adaptively.

Eligibility criteria:
inclusion criteria: - undergoing orthodontic treatment with fixed multibrackets appliance in the upper and lower arch exclusion criteria: * impacted canines * agenesis in the frontal region * maxillofacial surgery

Keywords: caries genetic prevention saliva s. mutans lifestyle microbiota exposure proline rich protein gene 1 (prh1) proline rich protein gene 2 (prh2) deleted malignant brain tumour (dmbt-1)
177lu-jh04 in patients with fap-positive tumors

Conditions: Patients with Advanced Metastatic FAP-Positive Tumors

Summary: this is a pilot study to assess the dosimetry, toxicity and response of 177lu-jh04, a new fap-targeted radiopharmaceutical, in patients with fap-positive tumors. all patients underwent 68ga-fapi pet/ct for selection and were successively divided into three groups of 3 people each.the three groups received successively an approximately 3.70 gbq (100 mci), 5.55 gbq (150 mci) and 7.40 gbq (200 mci) of 177lu-jh04 up to 4 cycles.

cancer-associated fibroblasts (cafs) are an integral part of the tumor microenvironment and present abundantly in the stroma of multiple tumor entities. fibroblast activation protein (fap), as a specific marker protein of cafs, is overexpressed on more than 90% of malignant tumors\& limited and expression in normal tissues, making it an appropriate target for diagnosis and therapy of numerous malignant tumors. currently, several radiopharmaceuticals targeting fap for radionuclide therapy have been developed, such as 177lu-fapi-46, 177lu-fap-2286, and showed high efficacy and reasonable toxicity profile in tumor treatment. 177lu-jh04, a novel radiopharmaceutical targeting fap, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. in this study, we assess the dosimetry, toxicity and response of 177lu-jh04 for the treatment of patients with advanced metastatic cancers after exhaustion of all other treatment options.

Eligibility criteria:
inclusion criteria: * progressive advanced metastatic tumors * tumors with high fap expression confirmed on 68ga-fapi pet/ct * adequate renal, haematological, and liver function * an eastern cooperative oncology group performance status of 0-2 exclusion criteria: * pregnant or lactating women * received other radionuclide therapy in the past 6 months * received chemotherapy, radiotherapy and other anti-tumor treatments in the past 28 days

Keywords: lu-177 fap tumor
efficacy and safety of lanreotide autogel® 60, 90 or 120 mg with lanreotide 40 mg prolonged release (pr) in acromegaly

Conditions: Acromegaly

Summary: the purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg pr in subjects with active acromegaly.


Eligibility criteria:
inclusion criteria: * subject has active acromegaly defined as elevated gh and igf-1 levels (measured at a central laboratory) as outlined below: * a serum level for igf-1 ≥1.3 x upper limit of normal range (uln) during the screening period (applicable to both treatment naïve subjects and subjects who have stopped treatment and undergone a washout period prior to visit 1(week -4). * subjects must have mean serum gh concentration ≥2.5 μg/l in a gh cycle (5 samples taken at 0, 30, 60, 90 and 120 minutes) during the screening period. * the subject has undergone surgical removal of an adenoma for acromegaly at least 3 months prior to screening, or is likely to require pituitary surgery in the future but not before completing at least 32 weeks of study treatment plus an additional follow up of 8 weeks for subjects taking part in the pharmacokinetics (pk) extension, or for whom pituitary surgery is not an option (due to contraindications, refusal etc.) and is therefore never likely to undergo pituitary surgery. exclusion criteria: * the subject has been treated with radiotherapy within 10 years prior to screening. * the subject has been treated with lanreotide autogel, lanreotide pr, pegvisomant, cabergoline or octreotide lar within 3 months of screening or octreotide immediate release (ir) or bromocriptin within 2 weeks of screening. * the subject has a history of or currently presents with clinically significant ventricular or atrial dysrhythmias ≥grade 2, using the national cancer institute common terminology criteria for adverse events (nci ctcae) v4.0. * the subject has uncontrolled diabetes (glycosylated haemoglobin (hba1c) \>8.5%).
addition of exenatide to insulin glargine in type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: this study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes. * have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study. have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study: 1. metformin (stable dose for 6 weeks) 2. pioglitazone (stable dose for 6 weeks) 3. a combination of metformin and pioglitazone (stable dose for 6 weeks) * have hba1c between 7.1% and 10.5%, inclusive. * have a body mass index (bmi) ≤45 kg/m2. * have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening). exclusion criteria: * have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study. * have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study. * are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control. * women who are breastfeeding. * have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer. * have had a kidney transplant or are currently on kidney dialysis. * have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years. * have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients. * have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study. * are currently on a weight-loss program or have been on one within 3 months of entering the study. * have had a blood transfusion or severe blood loss within 3 months of entering the study. * are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study. * have an irregular sleep cycle (for example, sleeping during the day and working during the night). * have a history of pancreatitis. * have received treatment with an experimental drug within 30 days of entering the study. * if on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis. * if on metformin, have had a radiologic contrast study performed within 48 hours of entering the study. * if on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.

Keywords: diabetes exenatide amylin lilly metformin pioglitazone insulin glargine